Clinical Trial of Vildagliptin in Early Parkinson's Disease

NCT06951334 | Not Yet Recruiting

• 2 other identifiers: [2024]746FirstSunYetSen
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigating the efficacy of Vildagliptin in delaying the progression of Parkinson's disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• The change in the third part of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) after 12 months of oral Vildagliptin treatment compared to baseline

  MDS-UPDRS Part III mainly includes motor symptoms (total score 0-132 points), with scores ranging from 0 to 132 The higher the symptom, the more severe it is.

  baseline, pre-intervention；12 months，month 12

Study Arms (2)

Conventional medication plus Vildagliptin treatment group

EXPERIMENTAL

Traditional dopamine preparations combined with vildagliptin treatment

Drug: Vildagliptin 50 mg bid

conventional medication treatment group

NO INTERVENTION

Only traditional dopamine preparations are used for treatment without additional intervention

Interventions

Vildagliptin 50 mg bid DRUG

Vildagliptin 50 mg bid for 12months

Conventional medication plus Vildagliptin treatment group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Patients aged 40 to 75 years who were diagnosed with Parkinson's disease according to the UK Brain Bank criteria within the past three years.
• : Participants must have received an optimized and stable dopaminergic medication regimen (dopamine agonists, levodopa, or monoamine oxidase B \[MAOB\] inhibitors, or combinations of these medications) determined by the study site investigators for at least one month prior to the baseline initiation of the trial drug, with the expectation that the participants will be able to continue this regimen for at least six months.
• : Sign the informed consent form

You may not qualify if:

• : Presence of motor fluctuations or motor complications (or both).
• : The presence of severe psychiatric disorders, such as severe (treatment-resistant) anxiety, depression, or schizophrenia, that cannot be effectively controlled by medication.
• : Atypical or secondary Parkinsonism
• : A score of 18 or lower on the Montreal Cognitive Assessment (MoCA) (range: 0 to 30, with a score of 26 or higher indicating normal cognitive function), indicating at least mild cognitive impairment.
• : Diabetes mellitus (Type 1 and Type 2), as well as prior treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.
• : Individuals with severe renal impairment (creatinine clearance \<30 ml/min), active liver disease, history of drug or alcohol abuse, idiopathic pancreatitis, chronic pancreatitis, or a history of pancreatectomy.
• : Individuals with a body mass index (weight in kilograms divided by the square of height in meters) less than 18.5, or those with a weight change exceeding 5 kilograms within the 3 months prior to screening.
• : Currently participating in other relevant clinical trials involving pharmacological or surgical treatments.
• : Other situations where the investigator believes that the subject is unable to participate in or cooperate with the entire assessment process of the clinical trial.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Interventions

Vildagliptin; BID protein, human

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04